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– Approval Based on Positive Results from the Phase 3 HD21 Trial for Stage IIb with Risk Factors/III/IV Hodgkin Lymphoma – ADCETRIS-based Combination Demonstrated Superior Safety Profile and Efficacy Compared to eBEACOPP, a Standard of Care Regimen in Europe – Second Approval in Frontline Hodgkin Lymphoma Broadens ADCETRIS’ Therapeutic Reach, Adding to Six Previously Approved, Distinct Indications for ADCETRIS in the European Union OSAKA, Japan & CAMBRIDGE, MA, USA I June 03, 2025 I Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS ® (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025. The approval for this ADCETRIS-based combination regimen, known as BrECADD, in frontline Hodgkin lymphoma is based on the results of the randomized Phase 3 HD21 trial. The study met its co-primary safety and efficacy endpoints, with BrECADD demonstrating significantly superior safety as assessed by treatment-related morbidity (TRMB) and non-inferior progression-free survival (PFS) in comparison to escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone (eBEACOPP), a standard of care treatment in Europe 1 . “Today’s approval represents a significant advancement for patients with Hodgkin lymphoma in the European Union,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. “This approval reinforces the role of ADCETRIS as a backbone in the treatment of specific lymphomas, offering healthcare professionals greater flexibility to tailor treatment plans according to individual patient needs. We’re proud to contribute another impactful option for those diagnosed with this challenging disease.” ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma, and has been previously approved as a therapy for adult patients in the European Union (EU) in six distinct indications. This decision marks the second approval for an ADCETRIS-based combination regimen for frontline Hodgkin lymphoma, broadening the spectrum of available treatments for patients who historically have had limited options. “With BrECADD, patients now have a treatment option that not only offers greater curative potential 2* but also significantly reduces treatment-related morbidity compared to eBEACOPP,” said Peter Borchmann, MD, PhD, University Hospital of Cologne, Germany, and trial chairman of the HD21 study. “This new ADCETRIS-based combination therapy may offer a new standard of care for frontline treatment of adults with advanced stage Hodgkin lymphoma, contributing to improved long-term outcomes for patients.” About the HD21 Trial The HD21 study is a Phase 3, multi-country, prospective, open-label, randomized, multicenter trial conducted by the German Hodgkin Study Group (GHSG) with a PET-response adapted designed to assess the feasibility, efficacy, safety and tolerability of BrECADD, a novel, rationally designed, CD30-intensified frontline regimen for patients with advanced Hodgkin lymphoma. Enrolled patients with newly diagnosed, Stage IIb with large mediastinal mass and/or extranodal lesions, Stage III or IV Hodgkin lymphoma were randomized to receive two cycles of either escalated BEACOPP or BrECADD, respectively, followed by interim PET staging. A decision is then made if patients received a further two or four cycles of escalated BEACOPP or BrECADD. The HD21 trial aims to evaluate a new treatment regimen to minimize side effects, while maintaining similar responses to treatment. The study has co-primary endpoints: safety is assessed by treatment-related morbidity (TRMB) (superiority), a novel endpoint focused on clinically relevant, acute toxicities of primary chemotherapy, and efficacy is assessed by PFS (non-inferiority). Secondary endpoints are tumor response (complete response [CR] rate), overall survival (OS), infertility rate at one year, second malignancies, frequency of adverse events, therapy adherence and quality of life. About ADCETRIS® (brentuximab vedotin) ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Pfizer’s proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumor cells. ADCETRIS injection for intravenous infusion has received FDA approval for eight indications: Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression in 2017, adults with pcALCL or CD30-expressing MF who have had prior systemic therapy in 2018, for previously untreated Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019. ADCETRIS received conditional marketing authorization from the European Commission in October 2012, and the specific obligations of the conditional marketing authorization were fulfilled in May 2022. The approved indications in the European Union are: (1) for the treatment of adult patients with previously untreated CD30-positive Stage III or IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine (AVD), (2) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (3) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (4) for the treatment of adult patients with relapsed or refractory sALCL, (5) for the treatment of adult patients with previously untreated sALCL in combination with CHP, (6) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (7) for the treatment of adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD). ADCETRIS has received marketing authorization by regulatory authorities in 80 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See Important Safety Information below. ADCETRIS is being evaluated broadly in more than 70 clinical trials, including a Phase 3 study in first-line Hodgkin lymphoma (ECHELON-1) and another Phase 3 study in first-line CD30-positive peripheral T-cell lymphomas (ECHELON-2), as well as trials in many additional types of CD30-positive malignancies. Pfizer and Takeda fund joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. Please see the full Prescribing Information, including BOXED WARNING, for ADCETRIS here . About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com . Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Footnotes: *While late relapse is rare, PFS status after 5 years does not guarantee cure. Patients should be monitored and encouraged to report any return of symptoms as appropriate. References: SOURCE: Takeda Pharmaceutical

Takeda has received approval from the European Commission (EC) for its Pfizer-partnered blood cancer drug Adcetris (brentuximab vedotin). The drug has been approved in combination with the chemotherapy regimen etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) to treat newly diagnosed stage 2b Hodgkin lymphoma (HL) in adults with risk factors/3/4. The authorisation follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the phase 3 HD21 study. The trial achieved its co-primary endpoints, with the Adcetris regimen demonstrating significantly improved safety, as assessed by treatment-related morbidity, and non-inferior progression-free survival compared to escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone (eBEACOPP), a standard of care in Europe. HD21 trial chairman, Peter Borchmann, University Hospital of Cologne, said: “With [the Adcetris regimen], patients now have a treatment option that not only offers greater curative potential but also significantly reduces treatment-related morbidity compared to eBEACOPP. “This new Adcetris-based combination therapy may offer a new standard of care for front-line treatment of adults with advanced stage HL, contributing to improved long-term outcomes for patients.” HL originates from abnormal lymphocytes and is distinguished from other types of lymphoma by the presence of Reed-Sternberg cells, which typically carry the CD30 protein on their surface. Approximately 82,469 new cases of the disease were reported globally in 2022. Adcetris, an antibody-drug conjugate (ADC) directed at CD30, is already approved in the EU for six other adult indications and the EC’s latest decision marks the second approval for an Adcetris-based combination regimen for front-line HL. Teresa Bitetti, president of Takeda’s global oncology business unit, said the approval “represents a significant advancement for patients with HL in the EU”. “This approval reinforces the role of Adcetris as a backbone in the treatment of specific lymphomas, offering healthcare professionals greater flexibility to tailor treatment plans according to individual patient needs. We’re proud to contribute another impactful option for those diagnosed with this challenging disease,” Bitetti added. Takeda is responsible for Adcetris’ commercialisation everywhere except the US and Canada, where Pfizer holds commercialisation rights.